Guidance On Reporting Adverse Events Following Immunization
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Refer to Reporting Adverse Events Following Immunization in Canada and Vaccine Safety and Pharmacovigilance in Part 2 for additional information about AEFI reporting.
Hepatitis A And Hepatitis B Vaccine Dosing Information
Usual Adult Dose for Hepatitis B Prophylaxis:
Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.
Usual Adult Dose for Hepatitis A Prophylaxis:
Primary immunization: 1 mL IM in the deltoid area at 0, 1 and 6 months.Alternatively, a 4 dose schedule given on days 0, 7, and 21 to 30 followed by a booster at month 12 may be used.
How Common Is Hepatitis A
In the United States, hepatitis A has become relatively uncommon. After the hepatitis A vaccine became available in 1995, the rate of hepatitis A infections declined by 95 percent in the United States. The number of reported cases of hepatitis A fell to 1,239 in 2014, the lowest yearly number of cases reported since the disease could be tracked.1 However, the number of reported cases increased to 3,366 in 2017, almost 3 times higher, mostly due to outbreaks among people who use drugs and people experiencing homelessness.1 Early reports suggest that the numbers of cases and outbreaks of hepatitis A increased further during 2018 and continue at these higher rates in 2019.2
Hepatitis A is more common in developing countries where sanitation is poor and access to clean water is limited. Hepatitis A is more common in parts of Africa, Asia, Central and South America, and Eastern Europe than it is in the United States.
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Is Hepatitis A Vaccine Safe To Take If I’m Pregnant Or Breastfeeding
There are no adequate or well-controlled trials of hepatitis A vaccine use in pregnant women. Therefore, hepatitis A vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known if the hepatitis A vaccine is excreted into human milk after administration to the mother. The manufacturer recommends caution when given it to nursing mothers.
What Are Some Things I Need To Know Or Do While I Take Hepatitis A Vaccine
- Tell all of your health care providers that you take hepatitis A vaccine. This includes your doctors, nurses, pharmacists, and dentists.
- If you have a latex allergy, talk with your doctor.
- This medicine may not protect all people who use it. Talk with the doctor.
- This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using hepatitis A vaccine while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
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What Are Some Side Effects That I Need To Call My Doctor About Right Away
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash hives itching red, swollen, blistered, or peeling skin with or without fever wheezing tightness in the chest or throat trouble breathing, swallowing, or talking unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat.
- A burning, numbness, or tingling feeling that is not normal.
- Trouble controlling body movements.
- Pain where the shot was given.
- Swelling, warmth, or redness where hepatitis A vaccine was given.
- Irritation where the shot is given.
Young children:
- Feeling fussy.
- Feeling sleepy.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
How Do People Get Hepatitis A
Hepatitis A virus is found in the stool of people with HAV infection. It enters the body through the mouth after someone handles something contaminated with HAV, or eats or drinks something contaminated with HAV.
People usually get hepatitis A by having close contact with a person who is infected, from food or drinks prepared by someone who is infected, or by eating shellfish harvested from sewage-contaminated water. After the virus enters the body, there is an incubation period lasting 2 to 7 weeks until illness begins.
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Persons With Chronic Diseases
Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information about vaccination of people with chronic diseases.
Chronic renal disease and patients on dialysis
HA vaccine is recommended for people with chronic renal disease or undergoing dialysis if they are at increased risk of HA infection or severe HA . A study assessing the immune response of hemodialysis patients to standard doses of HA vaccine demonstrated a good HA antibody response and no serious adverse effects.
Chronic liver disease
HA immunization is recommended for susceptible persons with chronic liver disease, including those infected with hepatitis C and chronic HB carriers, because they are at risk of more severe disease if infection occurs. Vaccination should be completed early in the course of the disease, as the immune response to vaccine is suboptimal in advanced liver disease.
Non-malignant hematologic disorders
People Whose Occupation Increases Their Risk Of Acquiring Hepatitis A
People who live or work in rural and remote Aboriginal and Torres Strait Islander communities in the Northern Territory, Queensland, South Australia or Western Australia are recommended to receive hepatitis A vaccine.
2 doses are required, with a recommended interval between doses of 6 months.
People who regularly provide care for Aboriginal and Torres Strait Islander children in the Northern Territory, Queensland, South Australia and Western Australia are recommended to receive hepatitis A vaccine.
2 doses are required, with a recommended interval between doses of 6 months.
Early childhood educators and carers are recommended to receive hepatitis A vaccine.
2 doses are required, with a recommended interval between doses of 6 months.
Carers of people with developmental disabilities are recommended to receive hepatitis A vaccine.
2 doses are required, with a recommended interval between doses of 6 months.
Plumbers and sewage workers are recommended to receive hepatitis A vaccine.
2 doses are required, with a recommended interval between doses of 6 months.
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Before Taking This Medicine
Hepatitis A and B vaccine will not protect you against infection with hepatitis C or E, or other viruses that affect the liver. It will also not protect you from hepatitis A or B if you are already infected with the virus, even if you do not yet show symptoms.
You should not receive this vaccine if you are allergic to yeast or neomycin, or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.
Before receiving this vaccine, tell the doctor if you have:
-
an allergy to latex rubber or
-
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments.
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
FDA pregnancy category C. Tell your doctor if you are pregnant. It is not known whether hepatitis A and B vaccine will harm an unborn baby. However, not vaccinating the mother could be harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with hepatitis.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of this vaccine on the baby.
What Is Hepatitis A Vaccination
Type: Injectable
Inactivated Hepatitis A vaccine is a safe and highly effective option.
- Inactivated virus vaccine
- Inactivated combination vaccine* with hepatitis B
- Inactivated combination vaccine with typhoid
Contraindications: Hepatitis Acontaining vaccines should not be administered to travellers with a history of hypersensitivity to any vaccine component, including neomycin. The Inactivated combination vaccine* with hepatitis B should not be administered to people with a history of hypersensitivity to yeast.
The tip caps of prefilled syringes of certain inactivated virus vaccines, the vial stopper, syringe plunger stopper, and tip caps of certain inactivated virus vaccines may contain dry natural rubber, which may cause allergic reactions in latex-sensitive people.
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Where Is It Found
HAV is common in areas with poor sanitation and restricted access to clean water. In countries with high HAV endemicity, as in some African and Asian countries, many adults are immune to HAV as a result of infection during childhood, and epidemics of hepatitis A are uncommon. In areas such as Central and South America, Eastern Europe and parts of Asia with intermediate HAV endemicity, childhood transmission is less common and so more adolescents and adults are vulnerable to infection outbreaks then become more likely. In countries such as Australia, the United States and Western Europe where there is low HAV endemicity, infection is less common in the general community, but disease occurs among people in high-risk groups as community-wide outbreaks.
What Is Hepatitis A Vaccine What Are The Uses For Hepatitis A Vaccine
Hepatitis A vaccine is used to prevent hepatitis A, a type of liver disease that is caused by the hepatitis A virus . Hepatitis A is usually spread when a person ingests fecal matter from contact with food, drinks, or objects which have been contaminated by feces or stool of an HAV-infected person. Hepatitis A infection can be mild with no symptoms or a serious illness that can rarely cause liver failure and death. Getting vaccinated against the hepatitis A virus is the best way to prevent these problems.
The hepatitis A vaccine does not cause hepatitis because it does not contain the live virus. It contains inactivated hepatitis A virus. The vaccine works by stimulating the body to produce antibodies, which are proteins that will fight and kill the virus and prevent hepatitis A infection.
The hepatitis A vaccine is used for the prevention of disease caused by hepatitis A virus in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.
Hepatitis A vaccine was approved in 2005.
What brand names are available for hepatitis A vaccine?
Havrix, Vaqta
Is hepatitis A vaccine available as a generic drug?
GENERIC AVAILABLE: No
Do I need a prescription for hepatitis A vaccine?
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Hepatitis A Vaccine: Canadian Immunization Guide
For health professionals
Last partial chapter update
: The immunoglobulin dosage for Hepatitis A pre-exposure and post-exposure prophylaxis was increased based on the Product Monograph update for GamaSTAN®, which is available on Health Canada’s Drug Product Database.
Last complete chapter revision: March 2018
Vaccination Is The Best Way To Prevent Hepatitis A And B Infection
Narrator: ÂYou are a traveller…Â .
Narrator: …and you are already dreaming of your next getaway. .
Disclaimer on-screen reads: TWINRIX is a combined hepatitis A and hepatitis B vaccine used in adults, adolescents, children, and infants over the age of 1 year to prevent hepatitis A and hepatitis B diseases
Narrator: ÂWhile your travel plans probably donÂt include hepatitis A or hepatitis B…Â .
Disclaimer reads: 100% protection cannot be guaranteed and booster doses may be required.
Narrator: Â…you know that many common travel activities can put you at risk of acquiring these two serious liver diseases…Â .
Disclaimer reads: TWINRIX does not protect against hepatitis C or E, and is not indicated to treat or reduce the severity of hepatitis A or B infections. .
Narrator: Â…which is why you plan on talking to your doctor about TWINRIX, right? … Of course, right…Â Â…because you are a traveller.Â
Video concludes with TWINRIX logo, GSK logo, You are a traveller slogan, and safety information: Very commonly reported adverse events in adults were pain or discomfort, redness at the infection site, headache, and tiredness. Common adverse events were swelling at the injection site, diarrhea, nausea and vomiting, and generally feeling unwell. Allergic reactions may also occur. Full product information can be found on Twinrix.ca. If you need to report an adverse event, please call 1-800-387-7374.
Twinrix.ca
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Who Is At Risk
Anyone who has not been vaccinated or previously infected can get infected with the hepatitis A virus. In areas where the virus is widespread , most hepatitis A infections occur during early childhood. Risk factors include:
- poor sanitation
- living in a household with an infected person
- being a sexual partner of someone with acute hepatitis A infection
- use of recreational drugs
- travelling to areas of high endemicity without being immunized.
Efficacy Of Hepatitis A Vaccines
Randomised controlled trials show that the vaccines have protective efficacy of nearly 100%.28,29 This is supported by the apparent eradication of hepatitis A from Aboriginal and Torres Strait Islander communities in north Queensland and the Northern Territory since the vaccination program started in these regions.15,17,30
A single dose of Hepatitis A vaccine can confer protection for several years. There is evidence to suggest that a single dose of HAV hepatitis A vaccine can be 100% efficacious in preventing hepatitis A infection in seronegative young children in the study period from 6 weeks to 15 months post vaccination.31 Other studies have demonstrated effectiveness of a single dose in preventing hepatitis A infection up to 7 years after vaccination.25,32
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Who Should Not Receive Hepatitis A Vaccine
There are a very few situations where the hepatitis A vaccine is not recommended. They include:
- If you have an illness causing a high temperature. In this situation, it is best to postpone vaccination until after you have fully recovered from the illness.
- If you have had an allergic reaction to the vaccine or to any of its components in the past.
- One type of vaccine should not be given to anyone who is known to be allergic to eggs.
- Children under the age of 1 year. However, the risk of hepatitis A in children under the age of 1 year is very low. The hepatitis A vaccine is not licensed for this age group.
The vaccine may be given if you are pregnant or breastfeeding and vaccination against hepatitis A is thought to be necessary.
Schedule : Controlled Drug
Schedule 8 drugs and poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use which have high potential for and . The possession of these medications without authority is an offence.
Like schedule 4 substances, the price of many Schedule substances are subsidized through the , some of which may require an authority. In addition, in some states, all drugs on schedule 8 require a doctor to have an S8 permit before prescribing treatment. For example, in the prescribing of Schedule 8 CNS stimulant medication requires authorisation from the NSW Ministry of Health and is generally restricted to specialists, such as paediatricians and psychiatrists. A GP cannot initiate the treatment, although they can prescribe in very limited circumstances, e.g. co-prescribing on behalf of the specialist and in rural areas, if the patient has been diagnosed with , a GP may apply for the authority to prescribe. Patients who may require Schedule 8 CNS stimulant medication should be referred to a specialist for assessment.
Examples:
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What Is The Hepatitis A Vaccine
Hepatitis A
The hepatitis A vaccine is a dose of inactive virus that stimulates your natural immune system. After the hepatitis A vaccine is given, your body makes antibodies that will protect you against the hepatitis A virus.
Vaccination for hepatitis A requires 2 shots, 6 months apart. The vaccine is given with an injection, into the muscle of the upper arm. If for some reason the second injection doesn’t take place at 6 months, you can receive the second dose at a later time.
If you need hepatitis B vaccination in addition to hepatitis A, you can do these individually or as a combined vaccine that covers both. The combination vaccine is given as 3 injections over a 6-month period–an initial dose, followed by a second dose 1 month later, and then a third dose 5 months after the second.
Hepatitis A In Australia
In recent years, hepatitis A notifications and hospitalisations have been low and trending down.1An increasing proportion of cases relate to travel to countries where hepatitis A is endemic.12-14
Hepatitis A in Aboriginal and Torres Strait Islander children
The hepatitis A vaccination program was initially established in north Queensland in 1999 for Aboriginal and Torres Strait Islander children aged 18 months.15 In 2005, it expanded to include all Aboriginal and Torres Strait Islander children aged 2 years in:
- the Northern Territory
- South Australia
- Western Australia
Before the vaccination program, rates of hepatitis A in Aboriginal and Torres Strait Islander communities were very high. Factors associated with high rates were poor living conditions, overcrowding and poor sanitation.16 The hepatitis A vaccination program for Aboriginal and Torres Strait Islander children in endemic areas substantially reduced hospitalisations and notifications for this population.17
Many Aboriginal and Torres Strait Islander children > 2 years of age in states and territories targeted by the hepatitis A vaccination program have received hep A vaccine. However, Aboriginal and Torres Strait Islander children remain at greater risk than non-Indigenous children of acquiring hepatitis A.17
See also Vaccination for Aboriginal and Torres Strait Islander people.
History of hepatitis A in Australia
More recently, Hepatitis A outbreaks have been associated with a common food source.17,21,22
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